It is a commonly known fact that pharmaceutical companies have suppressed unfavourable research. For example, in 1998, GlaxoSmithKline withheld clinical trial data, which showed that paroxetine (Paxil) was an ineffective treatment for depression in children and adolescents. Another example features GlaxoSmithKline. In an internal company memo, a GlaxoSmithKline employee stated that "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine". Moreover, internal industry memos were released during litigation against AstraZeneca. These memos revealed that the company withheld data on quetiapine (Seroquel) because its staff were not "...100% comfortable with this data being made publicly available at the present time...however I understand we have little choice...Lisa has done a great 'smoke-and-mirrors; job!" A 1999 AstraZeneca email begged the question, "The larger issue is how do we face the outside world when they begin criticizing us for suppressing data?" Pfizer, Parke-Davis, Merck, and other pharmaceutical companies have also been found to suppress clinical trial data and evidence of safety concerns in order to maintain favourable commercial profiles of their medications.

It is no surprise that a recent investigation by the Toronto Star found that, since 2008, at least 40 Canadian pharmaceutical companies have not only hidden, altered and destroyed data showing that their pharmaceutical products were tainted and unsafe, but also neglected to report evidence of side-effects experienced by patients when taking their medications.

The Star obtained records from the US Food and Drug Administration through the U.S. Freedom of Information Act because the US FDA inspects Canadian and international facilities when drugs that are manufactured in these facilities are intended to be distributed in the United States; however, unlike the FDA, which publicly posts investigation dates and results on its website, Health Canada does not transparently enforce drug manufacturing laws. Therefore, Canadian physicians and the public remain unaware of the problems that are revealed through any Canadian investigation. The FDA website provides dozens of warning letters to Canadian companies, detailing the atrocious conditions in these drug manufacturing facilities. In general, Health Canada conducts only a small fraction of the number of investigations that the FDA conducts.

Canadian generic giant, Apotex, has been cited for not only serious manufacturing violations, but also failing to report undesirable test results, as well as tampering with bacterial growth test records. Since 2008, the FDA has inspected Apotex at least nineteen times. In sixteen of these 19 investigations the FDA found that Apotex employed "objectionable" practices and had "repeated deficiencies". In one case, the FDA indicated that Apotex "failed to uphold 'its legal obligation'". These findings were not challenged by Apotex. Furthermore, the FDA has requested that Apotex investigate whether its middle and top management employees have been involved in data manipulation.

Taro Pharmaceuticals, Canadian generic manufacturer, was cited for keeping drugs on the market even though company testing showed that batches of the medication deteriorated prior to the expiry date indicated on the product label. Cangene Corp., another Canadian drug manufacturer failed to report of side-effects to authorities. These side-effects included, but were not limited to, blood clots and fever associated with their products. Although these findings were a result of US FDA investigation, the report also shows that the same drugs in question would have been prescribed to Canadians as well. Therefore, Health Canada would have been required to investigate these same drug manufacturers, but information about Health Canada's investigations are not made public. Canadian pharmaceutical policy expert Alan Cassels stated that "Health Canada is giving the least amount of information that they can...Instead of actually increasing people's confidence in the system, this kind of secrecy is degrading it." Cassels asks, "What's the reason for all the secrecy?"

Furthermore, the US FDA has instituted import bans on drugs made by Apotex (in India) and Ranbaxy, an India-based generic manufacturer, which also distributes pharmaceuticals to North America. The FDA found that India facilities are supplying Canada with medications that the US FDA knows have been adulterated. Following FDA inspections in 2008, the US government banned imports from two Ranbaxy facilities in India, which also distribute pharmaceuticals to Canada. In 2013, Ranbaxy's US subsidiary paid $500 million in criminal fines ($150 million) and settlements ($350 million) for its "false, fictitious, and fraudulent statements" to the FDA regarding its drug data and adulterated medications.

Terence Young, Member of Parliament for Oakville, Ontario has introduced Bill C-17 (Vanessa's Law), which aims to protect Canadians from unsafe drugs. Bill C-17 is proposed as an Act to amend the Food and Drugs Act. Alongside the Plain-Language Labeling, Bill C-17 will protect Canadians who take both prescription and over-the-counter medications by requiring more comprehensive safety warnings from drug manufacturers, giving Health Canada the power to order unsafe drugs off of the Canadian market when dangers become clear, require mandatory adverse drug reaction reporting, and create a robust warning system for patients. As of September 18, 2014, Bill C-17 has undergone its Second Reading in the Senate and has been referred to the Standing Senate Committee on Social Affairs, Science and Technology.

Recent claims have been made that Novartis downplayed the risks of its bisphosphonate, Zometa (zoledronic acid). Like Fosamax, which is also the subject of current litigation in Canada and the United States, Zometa is prescribed to treat and prevent osteoporosis. Zometa is primarily prescribed and administered intravenously to patients with cancer and has been associated with the same side effects as Fosamax. These side effects include bone pain, atypical fractures, and osteonecrosis of the jaw. Zometa has been prescribed to treat over 4 million patients in the United States and is approved for use in 95 countries globally.

The first Zometa personal injury case to was took place in 2009 and was initiated by Peggy Stevens, 57, of Missoula, Montana. Stevens had lymphoma and developed osteonecrosis of the jaw. The case was brought to trial on the bases of failure to properly warn and Stevens was awarded $3.2 million in compensatory damages. Her lawyers were able to provide evidence that Novartis had known about Zometa's risks, had communicative exchanges via email about these risks, and continued to suppressed the risks.

Most recently, in February 2013, Novartis Pharmaceuticals was found liable by a New York jury for $450,000 in damages and $10 million in punitive damages, totaling $10.45 million awarded to Barbara Davids. Davids was diagnosed with stage I breast cancer and was prescribed Fosamax to treat osteoporosis and Zometa to prevent or reduce the risk of bone fracture or damage from cancer that may have metastasized to the bone. Davids also developed osteonecrosis of the jaw after taking Zometa. In this case, a central claim was that the FDA had approved Zometa on the condition that Novartis provides the FDA with stronger safety information on the drug's association with osteonecrosis of the jaw and that Novartis had falsely labelled the severity of Zometa's risk factors. Davids sought compensatory damages under negligent failure to warn, among other theories. Davids also filed a lawsuit against Merck, the manufacturer of Fosamax.

A Federal Court judge in Australia refused to settle a case in which Australians claimed to be experiencing heart problems, such as heart attacks and strokes, while on Vioxx, an arthritis medication. The settlement would have provided maximum $2,000 for each of the 1700 plaintiffs in the class action suit against Merck's Australian subsidiary. The Australian judge, Justice Christopher Jessup, refused to the settlement because he believed that the settlement would have been unfair for plaintiffs who had a stronger case against the Merck regarding Vioxx.

The excessive profits made by the pharmaceutical industry are largely a result of illegal marketing, overcharging American consumers, taxpayers, and the United States' Medicare Part D, a program that helps seniors and people with disabilities afford their necessary medications. US Medicare is the largest purchaser of drugs worldwide and, by law, is required to pay inflated drug costs and is prohibited from seeking lower drug costs.

While patients struggle to afford their necessary medications, the 11 largest drug companies made over US$711 billion in profits between 2003 and 2012. In this time, drug companies' profits increased by 62% and in 2012, reached US$83.9 billion.

The CEOs of these 11 companies earned a combined total of US$1.57 billion. Compensation of drug companies' CEOs increased alongside a rise in illegal and improper industry conduct, including illegal marketing, price gouging of government programs, as well as other violations that are estimated to have risen by more than 500%.

Last week, the FDA approved Merck's new combination cholesterol-lowering pill, Liptruzet (Zetia and active ingredient in Lipitor, atorvastatin, now available as generic), without evidence for the drug's benefit. Even without evidence for benefit, Liptruzet is considered to be Merck's strategy to maintain its revenue from cholesterol medication sales in light of Vytorin's upcoming patent expiration in 2017. Questions and concerns are being raised about the FDA's regulatory judgement and Merck's marketing motives of Liptruzet.

According to Merck's announcement of Liptruzet on its company website, "No incremental benefit of LIPTRUZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established."

The FDA has remained silent about its reasoning for approving Liptruzet without evidence for benefit. Additionally, in the FDA's Drug Details of Liptruzet's approval, it is stated that "There are no Therapeutic Equivalents" for the drug when, in fact, there are already similar drugs on the market that are already being prescribed worldwide.

"It does not make any sense. I find it astonishing that after all the controversy about ezetimibe the FDA would approve another combination product with a drug that has been on the market for a decade and has not been shown to improve cardiovascular outcomes."

The FDA has rejected Merck's Liptruzet twice before, in 2009 and 2012, because the company neglected to provide necessary data.

Merck claims that it ensured that patients and doctors knew of the fracture risks associated with Fosamax, but "...early indications of a potential link to fractures were 'theoretical'." Merck's lawyer on the case, Chilton Varner, still maintains that the data on Fosamax shows fewer fractures than patients on placebo. The FDA determined, though, that the benefits of Fosamax decline after 3-5 years of treatment.

Merck has won the most recent Fosamax femur-fracture trial in a New Jersey federal court, when it was determined that the plaintiff's broken leg was not related to her Fosamax treatment. According to the plaintiff's lawyer, Paul Pennock, Merck was aware that Fosamax could trigger atypical femur fractures, but neglected to provide such information to either regulators or doctors until Fosamax's market exclusivity had ended in 2008. Since 2008, Fosamax sales decreased by 75%, from US$3 billion in 2007 to US$676 million in 2012. The jury's decision in favour of Merck stated that "[t]he company provided appropriate and timely information about Fosamax to consumers and the medical, scientific and regulatory communities."Alternatively, Merck lost a Fosamax case earlier this year. The New York jury decided that Merck had not adequately disclosed the bone-related risks associated with Fosamax and failed to warn patients of potential jawbone issues. The plaintiff, Scheinberg, expressed that "[i]n reading the patient insert, it informed me and I understood from reading it that Fosamax would prevent fractures in patients like me." Scheinberg continued that she trusted the information provided by Merck and would not have taken Fosamax had she known that it did not prevent fractures. (Fosamax Products Liability Litigation, re: Scheinberg v. Merck.) While the claim that Fosamax was defective was thrown out, it was agreed that more effective and informative labeling of Fosamax could have been beneficial. In light of this win, the plaintiff's lawyer, Tim O'Brien, stated that "[w]ith this victory, this litigation has a renewed purpose and renewed focus."Currently, seven of approximately 4,000 Fosamax cases have been tried. Merck won 5/7 tried cases.

In 2012, five pharmaceutical companies paid almost $5.5 billion to resolve allegations by the US Department of Justice for employing fraudulent marketing practices and off-label promotion of medicines. Here is a brief summary of the companies and fines:

According to the Canadian Centre for Policy Alternatives (CCPA), Health Canada's drug approval process is embedded in a structure that is inherent with conflicts of interest (COI) with its stakeholders. At almost every stage of the drug approval process, the pharmaceutical industry is involved, financially or otherwise. In addition, industry lobbyists are campaigning for faster drug approval times, which has led to higher rates of approval of dangerous drugs. The dangers of these drugs are typically only realized after widespread prescription and use of these drugs. Examples of drugs that underwent faster approval and were recognized to be dangerous only after widespread prescription, include the NSAIDs Vioxx (rofecoxib) and Bextra (valdecoxib).

Furthermore, industry lobbyists are campaigning for the abolition of Health Canada's current regulations that prohibit direct-to-consumer advertising (DTCA) of prescription drugs. DTCA is an extremely effective and successful promotional tool for drug companies, as evidenced by data on drug promotion and prescription rates in the United States and New Zealand, the only two countries that allow DTCA of prescription drugs. It is important to note, though, that drug companies often mask DTCA as "public education" or "health education," when the advertisements downplay side effects and exaggerate benefits of medications.

According to this op-ed, "Health Canada wrapped up its “stakeholder” consultations in late January. The pro-industry recommendations that will emerge are almost certain to get two thumbs up from the present federal government."

Merck is currently involved in litigation over claims that Fosamax (alendronate sodium) caused femur fractures in its users. Merck is reported to have ignored Fosamax's safety risks, which means that the company did not provide necessary safe prescribing information to physicians and patients. According to Staton (2013), Merck ignored data that indicated that long-term use of Fosamax increased women's risk of atypical femur fractures.

So far, Merck has lost two of seven cases regarding Fosamax use and jawbone fractures and death. Merck faces approximately 900 more lawsuits claiming that Foxamax is linked to jawbone fractures and according to Bloomberg, Merck faces over 3,300 more lawsuits claiming that Fosamax causes femur fractures.

Take a look at RxISK.org's info on reported side effects from Fosamax here.

Author:

Adrienne is currently completing her J.D. (2019) at Osgoode Hall Law School. She received her M.A. (2012) and Ph.D. (2016) in Health Policy & Equity with a focus on pharmaceutical policy, regulation, and patient safety.